At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 15 enrolled
Drug / intervention
0.04 mg Lu AE04621 +7 moredrug
Likely dose
0.04 mg Lu AE04621from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Interventional, Open-label, Exploratory Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AE04621 and the Active Metabolite Lu AA40326 After Ascending Oral Doses of Lu AE04621 to Patients With Parkinson's Disease
In Brief
A Phase 1 clinical trial evaluating 0.04 mg Lu AE04621, 0.08 mg Lu AE04621, and 6 other interventions for Parkinson Disease. Completed, enrolled 15 participants across 4 sites.
Detailed Summary
To evaluate the safety, tolerability, pharmacokinetics, and efficacy of the Lu AE04621 and metabolite after ascending oral doses of Lu AE04621 in patients with Parkinson's Disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJan 2016
First PostedJan 2016
Primary CompletionDec 2016
TodayJul 2026
First PostedJan 7, 2016
Enrollment StartJan 1, 2016
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.5 years ago
Interventions
0.04 mg Lu AE04621drug
0.04 mg dose group
0.08 mg Lu AE04621drug
0.08mg dose group
0.2 mg Lu AE04621drug
0.2 mg dose group
0.4 mg Lu AE04621drug
0.4 mg dose group
0.6 mg Lu AE04621drug
0.6 mg dose group
0.8 mg Lu AE04621drug
0.8 mg dose group
1.0 mg Lu AE04621drug
1.0 mg dose group
1.2 mg Lu AE04621drug
1.2 mg dose group